Quality Engineering Specialist

Quality Engineering Specialist – CH (Contract Role)

📅 Contract Duration: 03/02/2025 – 01/08/2025

📍 Location: Switzerland (Hybrid – max. 2 days home office)

🌍 Languages Required: Fluent English (German is a plus)

About the Role

We are looking for an experienced Quality Engineering Specialist to support qualification activities in a biotechnology or pharmaceutical environment. This role involves ensuring compliance with GMP standards, reviewing and approving qualification documents, and assessing quality risks related to technical facilities, equipment, and systems.

Key Responsibilities

✔ Daily oversight of qualification activities for technical facilities, equipment, and systems.

✔ Review and approval of qualification documents (FAT/SAT/IQ/OQ/PQ).

✔ Change control assessment to maintain a validated state and ensure compliance.

✔ Deviation investigation and risk assessment (e.g., GMP-FMEA).

✔ Support internal & external audits as a QA representative.

✔ Develop and enhance qualification strategies and provide training as needed.

✔ Monitor regulatory trends and ensure compliance with industry expectations.

Key Requirements

✅ Experience in a GMP-regulated biotechnology or pharmaceutical environment.

✅ QA qualification experience with a strong understanding of FAT/SAT/IQ/OQ/PQ.

✅ Proactive mindset, strong communication skills, and ability to work cross-functionally.

✅ Fluent English (spoken & written).

✅ Hybrid work model (max. 2 days home office).

Beneficial Skills (Nice to Have)

➕ Experience in risk analysis.

➕ German language skills.

➕ Familiarity with SAP, DMS, and TrackWise.

➕ Strong independent and proactive work approach.

📩 Interested? Apply now and contribute to quality excellence in a dynamic environment!